Top Banner
1 www.orchidpharma.com Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters: ORCD.BO
20

1 Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

Dec 22, 2015

Download

Documents

Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

1www.orchidpharma.com

Orchid Chemicals & Pharmaceuticals Ltd.

Creating Sustainable Value

November 2010

BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters: ORCD.BO

Page 2: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

2www.orchidpharma.com

Disclaimer

This presentation includes forward-looking statements / projections, which are based on current expectations

and forecasts about future events. Such statements involve known / unknown risks, uncertainties and other

factors and may cause and defer the actual results materially. Such factors include, but are not limited to,

changes in local and global economic conditions, Orchid Chemicals & Pharmaceuticals Ltd. (‘Orchid’ or the

‘Company’) ability to successfully implement its strategies, the market acceptance and demand of the

Company’s products and services, the Company’s growth rates, expansion, technological change and the

Company’s exposure to market risks. By this nature, these indications and projections are only estimates and

actual results could differ from these in the future.

These materials are not an offer for sale of securities in the United States or in any other jurisdiction. No

securities of the Company may be offered or sold in the United States absent registration or an exemption from

registration under the U.S. Securities Act of 1933, as amended. The Company does not intend to register any

of its securities for offer or sale in the United States or elsewhere, or to conduct a public offering of securities in

the United States or elsewhere. No money or other consideration is being solicited pursuant to these materials.

Page 3: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

3www.orchidpharma.com

Orchid Chemicals & Pharmaceuticals

Business

Vertically integrated global pharmaceutical company Established research, manufacturing and marketing capabilities Multi-therapeutic, multi-product global business Active Pharmaceutical Ingredients (API), finished dosage forms and drug discovery

Key Product Offerings

Fully integrated API and Finished Dosage Form product offerings Oral Antibiotics Diverse (oral) multi-category non-antibiotic product range (Non-Penicillin/Non-Cephalosporin)

Facilities

2 API manufacturing sites in India and 1 API manufacturing site in China 3 formulations manufacturing sites in India, and 3 research campuses in India Manufacturing facilities approved by US FDA, UK MHRA, EDQM, DMA, MCC and TGA R&D facility accredited by National GLP Authority of India (aligned to OECD principles of GLP)

Employees Human resource base of 4000 plus – includes over 700 scientific & technical manpower in R&D

and manufacturing, and around 1000 field personnel in domestic formulations

Financials*

Financials are on consolidated basis

Q2 FY11 Turnover: Rs 4,024 mn (US$ 91 mn) / H1 FY11 Turnover: Rs 7,670 mn (US$ 173 mn) FY10 Turnover: Rs 13,435 mn (US$ 298 mn)

* USD figures based on exchange rate of Rs 44 = 1$ (Q2FY11 & H1 FY11) / Rs 45 = 1$ (FY10)

Page 4: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

4www.orchidpharma.com

Amongst the Top-15 Indian pharma companies, a status achieved in just 13 years of operationsAmongst the Top-15 Indian pharma companies, a status achieved in just 13 years of operations

Largest manufacturer-exporter of cephalosporin products in India; Amongst the top exporters of all pharmaceutical products in IndiaLargest manufacturer-exporter of cephalosporin products in India; Amongst the top exporters of all pharmaceutical products in India

Recipient of several awards from Government of India, Confederation of Indian Industry, Madras Management Association and other national and international agenciesRecipient of several awards from Government of India, Confederation of Indian Industry, Madras Management Association and other national and international agencies

Partner of Choice for ‘Competitive Excellence’ & ‘Contract Research - Collaborative Drug Discovery’ awarded by Frost & SullivanPartner of Choice for ‘Competitive Excellence’ & ‘Contract Research - Collaborative Drug Discovery’ awarded by Frost & Sullivan

Amongst the Top-5 cephalosporin antibiotic producers of the worldAmongst the Top-5 cephalosporin antibiotic producers of the world

Orchid’s Domain Leadership

Leader in high technology life-saving antibiotics ; cephalosporins, penicillins / betalactams and carbapenems

Complex non-penicillin, non-cephalosporin products

PresencePresence

Committed to a culture of high standards in safety, health and environmentCommitted to a culture of high standards in safety, health and environment

Page 5: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

5www.orchidpharma.com

Become an Integrated Pharmaceutical

Corporation of Global Scale and Standing,

with a Comprehensive Coverage from

Discovery to Delivery

Key Differentiators

Orchid’s Vision is to…

• API to FDF

• Discovery to Delivery

• Global SCM

• US FDA• UK MHRA• EDQM• SA MCC• TGA• DMA

• Joint Ventures

• Collaborations

• License Agreements

• cGMP

• cGLP

• ISO

• OHSHAS

State-of-the-art R&D and

Manufacturing Facilities

End-to-end connectivity

Stringent quality,

regulatory compliance

Global alliances

and partnerships

Page 6: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

6www.orchidpharma.com

Orchid Chemicals & Pharmaceuticals Ltd.

Orchid Research Laboratories Ltd., Chennai

NCPC Orchid Pharmaceuticals Company Ltd. China

Orchid Pharma Japan K K, Tokyo

Orchid Pharmaceuticals, Inc., Delaware, USA

Orchid Pharmaceuticals SA (Pty) Ltd. South Africa

Bexel Pharmaceuticals Inc., Union City, CA, USA

Diakron Pharmaceuticals Inc. San Diego, USA

Orchid Europe Ltd. London, UK

Orgenus Pharma Inc., Princeton, NJ, USA

Wholly owned subsidiary for drug discovery and development

Wholly owned subsidiary for business development (generics and CRAMS) in Japan

50:50 joint venture for manufacture of sterile cephalosporin APIs in China

Wholly owned subsidiary for rendering select services in US

Wholly owned subsidiary for undertaking South African generics foray

Wholly owned subsidiary for drug discovery and development in US

Affiliate (planned to be a subsidiary) for discovery and development of new cardiovascular drugs

Wholly owned subsidiary for generics foray in Europe

Wholly owned subsidiary

Orchid Group Corporate Structure

Page 7: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

7www.orchidpharma.com

API facilities (Alathur, Chennai)

Largest cephalosporin API manufacturing complex

Approved by US FDA, UK MHRA and other international regulatory agencies

Variety of non-sterile and sterile (crystalline & lyophilised) APIs

High levels of throughput and manufacturing integration (980 MT of capacity per annum)

State-of-the-art infrastructure designed for highest levels of process efficiencies and environmental friendliness

GMP - Approved (WHO)

US-FDA – Approved (Nov’02, Sep’03 & Dec’06)

EDQM – Approved (Sep’03)

MHRA – Approved (Jan’06)

Hamburg Health Authority – Approved (Jan’06)

Australian-TGA - Approved (Feb’03)

ISO 9001:2000-certified Quality Management System (Re-certified in May’08)

ISO 14001-certified Environment Management System (Re-certified in May’08)

Danish Medicines Agency (EU-GMP) – Approval (Jan’09)

Pharmaceuticals & Medical Devices Agency (PMDA, Japan) – Oct’09)

Page 8: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

8www.orchidpharma.com

API facilities (Aurangabad) Multi-site API complex with dedicated facilities for

Penicillins Sterile Carbapenems Non-penicillin, Non-cephalosporins (NPNC)

Facilities designed for automated production

Manufacturing capacities : 48 MT for Penicillins, 12 MT for Sterile Carbapenems and 120 MT for NPNC

Approvals: UK MHRA (Approved - Jan ’07) US FDA (Approved - Feb ’07) OHSAS 18001:1999 Danish Medicines Agency [EU-GMP] (Approved - Jan ’09) WHO GMP Audit (Approved - Apr ‘10)

ISPE, INTERPHEX and Pharmaceutical Processing

Facility Awards 2009

Sterile Carbapenem Facility

Page 9: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

9www.orchidpharma.com

Formulation Facilities – Advanced Markets (Irungattukottai, Chennai)

Large state-of-the-art oral dosage form complex with multi-therapeutic facilities

World-class facilities with US FDA & UK MHRA and other international regulatory approvals

High throughput Oral cephalosporin formulations facility

Pilot and commercial scale NPNC (non-antibiotic) dosage forms plant

Global scale capacities

Page 10: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

10www.orchidpharma.com

Highlights of Orchid’s Generics Contracts – US, EU model

Orchid has long term partnerships with leading global generic players in US and Europe to distribute its products in the respective markets.

Orchid licenses the generic products in return for development cum licensing fees received from the partners.

Orchid manufactures and supplies the products from its US FDA, UK MHRA approved facilities based on pre-agreed costs of goods and also receives share of revenues or net profits as per agreements.

The arrangements incorporate mutual performance parameters in terms of market and supply performance.

The typical initial term ranges upwards of five years from product launch, with the agreements providing for renewal.

The partnerships have been expanded in terms of product range and extended in terms of geographic coverage reflecting Orchid’s performance and partnership equity

Orchid is currently working on creating front-end marketing organisations of its own in the advanced markets

Page 11: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

11www.orchidpharma.com

Novel Drug Delivery Systems (NDDS)

A new initiative to support product life cycle management of established drugs

Undertakes development of new dosage forms and strengths to enhance the efficacy and safety of existing drugs

Develops novel combinations of existing drugs for better compliance and / or synergistic effect

Platform technologies deployed to undertake NDDS developments

Strategy focuses on developing NDDS on bench scale and establishing limited proof-of-concept

Business strategy envisages collaborative approaches with MNCs and specialist delivery companies for further studies and eventual commercialization

Also provides support to development of conventional and novel formulations for New Chemical Entities

Page 12: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

12www.orchidpharma.com

Orchid Research Laboratories Limited (ORLL)

BusinessBusiness

A wholly owned subsidiary of Orchid Chemicals & Pharmaceuticals for undertaking drug discovery and development

An integrated research company with end-to-end capabilities in drug discovery and development

Among the top ranked pharmaceutical discovery entities in India, with global standing

Objectives Discovery and development of New Chemical Entities (NCEs) Custom Research and Manufacturing Services (CRAMS)

FacilitiesFacilities

Drug Discovery Centre, Biology Centre, Animal House cum Pre-clinical Facility, CMC Facility, Analytical Centre, Formulation Facility in Chennai, India

R&D Facilities GLP accredited by National GLP Authority of India, aligned with OECD Principles

Employees Scientific base of 130 plus with several doctoral and post-doctoral scientists Access to 200 plus scientists in other R&D and technical domains of the Parent organization

RecognitionRecognition Partner of choice in ‘Contract Research – Collaborative Drug Discovery’ awarded by Frost &

Sullivan

Page 13: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

13www.orchidpharma.com

Orchid Research Laboratories Ltd (ORLL) Animal House facility

Microbiology Facility

Microbiology Capabilities: MRO

Process Research & Development

Molecular modeling

IPM

Medicinal Chemistry

Analytical Chemistry

Assay Development

Microbiology in vitro functional capabilities

Microbiology in vitro hit profiling capabilities

Microbiology in vivo capabilities

Pre-Form/Formulation and DMPK

Toxicology Capabilities

Access to Parent’s Process Research and Pharma Research infrastructure

Special competencies

High quality infrastructure

130 plus scientists exclusively for drug discovery and drug biology. Supported by access to the parent’s process research and pharmaceutical capabilities, as needed

Has the capability to link up with clinical research organizations for human clinicals

Orchid’s integrated drug discovery and development infrastructure helps simultaneous, fast-track pursuit of multiple therapeutic programs

GLP Certified

Page 14: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

14www.orchidpharma.com

ORLL’s product and services strategy

Project based services

Collaborative Drug Discovery

Proprietary Drug Discovery

Pfizer Biovitrum Dermact etc. FTE or Fee for Service models

MNC oriented Therapeutic area based Risk-reward shared models

Multiple TAs PCC in animals POC in humans Out-licensing

Page 15: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

15www.orchidpharma.com

IPM

Patent Applications Filed : Total - 64414

2816

187399

NCE Process Biotech NDDS Generics

Patents Published : 226

13

86

136

NCE Process Biotech NDDS

Draft, file and prosecute high quality patent applications

644 patent applications filed in various national and international patent offices

Includes 187 patent applications for NCEs, 28 for NDDS and 14 for biotech

Several patent and search data bases

Prepare novelty / infringement reports

Monitor competitors’ patent portfolio

Coordinate with foreign patent attorneys

Prepare patent evaluation reports

Support Business Development & clarify portfolio related queries

Robust IPM systems to protect inventions, secure intellectual property and assure client confidentiality

Page 16: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

16www.orchidpharma.com

ORLL’s multi-therapeutic, multi-lead discovery programNCE Development Status

1

2

1

3

1

1

Discovery Early Pre-clinical

Late Pre-Clinical

Regulatory Toxicology

Phase 1 Clinical

Phase II Clinical

3

2

2

2

NCE

Tyrosine-TZD, Non-PPAR molecule

3

DPP IV Inhibitor

Novel

Th1 / Th2 Cytokine Synthase Inhibitor

Diabetes

Therapeutic Segment

Inflammation

Oncology

(Non-Cytotoxic)

PDE IV Inhibitor

TNF Inhibitor

STAT 3 / IL-6 Inhibitor

HDAC Inhibitor

Anti-Infectives

Oxazolidinone

Cephalosporin

Betalactamase Inhibitor

1

CNS

Obesity

1

Novel

Novel

1 Oral Direct Thrombin InhibitorClotting Disorders

Page 17: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

17www.orchidpharma.com

Orchid’s multi-horizon strategy would focus on a larger basket of oral products and new value adding niche opportunities

New Drug Discovery

Novel Drug Delivery

CRAMS

Generics for regulated markets

Branded for emerging markets

Branded for India

for in-house generics

for regulated markets

for emerging markets

Horizon 1 - API

Horizon 2 - Formulations

Horizon 3 – Innovation

Page 18: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

18www.orchidpharma.com

Growth strategy

Orchid

Existing Business

API / Oral FDF / CRAMS / NDDS

Inorganic Strategies

(Front-end Mktg / in-licensing of products)

New niche Initiatives

(New product segments)

Target to grow topline by 15-20% y-o-y

Strong operational cash flow going forward based on niche product opportunities

Orchid recently acquired US-based marketing company Karalex Pharma, LLC.

Page 19: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

19www.orchidpharma.com

Orchid’s Value Proposition

DOMESTICFORMULATIONS CRAMS

GLOBALGENERICS

(ORAL)

NDDS NCEsGLOBAL

APIs

Formulations InnovationAPI

State-of-the-art manufacturing infrastructure; two API sites, one oral generic formulations facility for advanced markets, two formulations facilities for certain emerging markets and R&D and drug discovery facilities

Global regulatory compliance, including US FDA, UK MHRA and DMA

Multi-therapeutic product portfolio, with an increased focus on oral cephalosporin and non-penicillin, non-cephalosporin (NPNC) products

Long term contracts with Hospira / other innovators for supply of APIs with assured capacity utilization

Integrated drug discovery capabilities with proprietary NCE pipeline as well as custom research and collaborative drug discovery

Financial flexibility to identify growth opportunities across the value chain

Page 20: 1  Orchid Chemicals & Pharmaceuticals Ltd. Creating Sustainable Value November 2010 BSE: 524372 NSE: ORCHIDCHEM Bloomberg: OCP@IN Reuters:

20www.orchidpharma.com

THANK YOUFor any information or clarifications, please visit www.orchidpharma.com

or call

Ch Ram, Head - Communications & Investor Relations

on +91 98400 11626 / [email protected]

© 2010 Orchid Chemicals & Pharmaceuticals Ltd., All Rights Reserved.

This material was used during an oral presentation; it is not a complete record of the discussion. This work may not be used, sold, transferred, adapted,

abridged, copied or reproduced in whole on or in part in any manner or form or in any media without the prior written consent. All product names and

company names and logos mentioned herein are the trademarks or registered trademarks of their respective owners.